✨ Medicines Consent Notices




6 JUNE 2013 NEW ZEALAND GAZETTE, No. 72

1921

Medicines Act 1981

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Empliciti

  • Active Ingredient: Dapagliflozin propanediol 12.3mg equivalent to dapagliflozin 10mg
  • Dosage Form: Film coated tablet
  • New Zealand Sponsor: AstraZeneca Limited
  • Manufacturers: Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
    Bristol-Myers Squibb Company, Indiana, United States of America

Product: Juvicor

  • Active Ingredients: Simvastatin 10mg
    Sitagliptin phosphate monohydrate 128.5mg equivalent to sitagliptin 100mg
  • Dosage Form: Film coated tablet
  • New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
  • Manufacturers: MSD International GmbH (Ireland), County Tipperary, Ireland
    Merck Sharp & Dohme Limited, Northumberland, United Kingdom

Product: Juvicor

  • Active Ingredients: Simvastatin 20mg
    Sitagliptin phosphate monohydrate 128.5mg equivalent to sitagliptin 100mg
  • Dosage Form: Film coated tablet
  • New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
  • Manufacturers: MSD International GmbH (Ireland), County Tipperary, Ireland
    Merck Sharp & Dohme Limited, Northumberland, United Kingdom

Product: Juvicor

  • Active Ingredients: Simvastatin 40mg
    Sitagliptin phosphate monohydrate 128.5mg equivalent to sitagliptin 100mg
  • Dosage Form: Film coated tablet
  • New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
  • Manufacturers: MSD International GmbH (Ireland), County Tipperary, Ireland
    Merck Sharp & Dohme Limited, Northumberland, United Kingdom

Product: Oxytocin BNM

  • Active Ingredient: Oxytocin 5IU/mL equivalent to 8.3mcg/ml
  • Dosage Form: Solution for injection
  • New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
  • Manufacturer: Rotexmedica GmbH, Trittau, Germany

Product: Oxytocin BNM

  • Active Ingredient: Oxytocin 10IU/mL equivalent to 16.6mcg/ml
  • Dosage Form: Solution for injection
  • New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
  • Manufacturer: Rotexmedica GmbH, Trittau, Germany

Dated this 29th day of May 2013.

DR STEWART JESSAMINE, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Herceptin

  • Active Ingredient: Trastuzumab 150mg
  • Dosage Form: Powder for infusion
  • New Zealand Sponsor: Roche Products (NZ) Limited
  • Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
    F Hoffmann-La Roche Limited, Basel, Switzerland


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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 72





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
29 May 2013
Medicines, Distribution, Consent, New Zealand, Pharmaceuticals
  • Dr Stewart Jessamine, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Distribution, Consent, New Zealand, Pharmaceuticals